UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028829 |
|---|---|
| Receipt number | R000032967 |
| Scientific Title | The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2019/02/25 09:20:12 |
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Basic information
Public title
The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Acronym
The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Scientific Title
The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Scientific Title:Acronym
The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Region
| Japan |
Condition
Condition
depressive symptoms
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to conduct a workplace environment improvement program for small-sized enterprises and evaluate their effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of indicator related to psychosomatic stress reaction at 3 months after the start of intervention.
Key secondary outcomes
Changes of indicator related to job stressor and psychosocial support at 3 months after the start of intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: implement the workplace environment improvement program for 3 months.
Interventions/Control_2
Control group: after completing the workplace environment improvement program of the intervention group, implement the same intervention program.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Workers working at small-sized enterprises
2. Study participants with consent
Key exclusion criteria
1. Study participants without consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisanori Hiro |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Mental Health, Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL
093-691-7475
hiro@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Hino |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Mental Health, Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL
093-691-7475
Homepage URL
ayako-hino@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Mental Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
General incorporated foundation (Anshin Zaidan)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032967
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
